Federal Register / Vol. 70, No.
248 / Wednesday, December 28, 2005 / Notices
percent of the voting shares of LNB
Bancorp, Inc., Lorain, Ohio, and thereby
indirectly acquire voting shares of the
Lorain National Bank, Lorain, Ohio.
Board of Governors of the Federal Reserve
System, December 22, 2005.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E5–7944 Filed 12–27–05; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P–0244]
Determination That DECADRON
(Dexamethasone) Tablets, 1.5
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that DECADRON (dexamethasone)
tablets, 1.5 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
dexamethasone tablets, 1.5 mg.
FOR FURTHER INFORMATION CONTACT:
Janice L. Weiner, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (the 1984
amendments) (Public Law 98–417),
which authorized the approval of
duplicate versions of drug products
approved under an ANDA procedure.
ANDA sponsors must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is typically a
version of the drug that was previously
approved. Sponsors of ANDAs do not
have to repeat the extensive clinical
testing otherwise necessary to gain
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approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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76851
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
DECADRON (dexamethasone) tablets,
1.5 mg, are the subject of approved NDA
11–664 held by Merck & Co., Inc.
(Merck). According to Merck’s 1997
annual report, the 1.5–mg dose strength,
among others, of DECADRON
(dexamethasone) tablets, a synthetic
adrenocortical steroid, was
discontinued in 1997. In a citizen
petition dated June 16, 2005 (Docket No.
2005P–0244), submitted under 21 CFR
10.30, ECR Pharmaceuticals requested
that the agency determine whether
DECADRON (dexamethasone) tablets,
1.5 mg, were withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
Merck’s DECADRON (dexamethasone)
tablets, 1.5 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. FDA has reviewed its files
for records concerning the withdrawal
of DECADRON (dexamethasone) tablets,
1.5 mg, from sale. There is no indication
that the decision not to market
DECADRON (dexamethasone) tablets,
1.5 mg, commercially is a function of
safety or effectiveness concerns. FDA
has independently evaluated relevant
literature and data for possible concerns
regarding the safety or effectiveness of
this drug product. FDA has found no
information that would indicate that
this product was withdrawn for reasons
of safety or effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that for the reasons outlined
previously, DECADRON
(dexamethasone) tablets, 1.5 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list DECADRON
(dexamethasone) tablets, 1.5 mg, in the
PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs for
dexamethasone tablets, 1.5 mg, that
comply with relevant legal and
regulatory requirements may be
approved by the agency.
Dated: December 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7875 Filed 12–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0488]
Animal Drug User Fee Act; Public
Meeting
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice of public meeting;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting on the Animal Drug User
Fee Act (ADUFA) to seek public
comments relative to the program’s
overall performance and reauthorization
as directed by Congress.
Date and Time: The public meeting
will be held on February 24, 2006, from
9 a.m. to 5 p.m. Requests to make a
presentation at the meeting must be
received by February 10, 2006. Written
comments regarding this meeting may
be made by March 26, 2006, to the
Division of Dockets Management (see
ADDRESSES).
Location: The meeting will be held at
the DoubleTree Hotel, Plaza II and III,
1750 Rockville Pike, Rockville, MD
20852. Registration is not required to
attend the meeting. Parking is limited,
so we recommend arriving by subway
(Metro rail) if possible. The DoubleTree
Hotel is accessible from the Metro rail’s
red line at the Twinbrook station.
ADDRESSES: You may submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments.
FOR FURTHER INFORMATION CONTACT:
Aleta Sindelar, Center for Veterinary
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 76852 Federal Register / Vol. 70, No. 248 / Wednesday, December 28, 2005 / Notices
Medicine (CVM) (HFV–3), Food and
Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9004,
FAX: 240–276–9020, e-mail:
asindela@cvm.fda.gov.
Transcripts: Meeting transcripts will
be made available on CVM’s Web site
(http://www.fda.gov/cvm/adufa.htm)
approximately 30 working days after the
meeting. The transcript will also be
available for public examination at the
Division of Dockets Management (see
ADDRESSES), between 9 a.m. and 4 p.m.,
Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
In the language authorizing the
Animal Drug User Fee Act, Congress
directed the Secretary of Health and
Human Services (the Secretary) to
consult with the Committee on Energy
and Commerce of the House of
Representatives, the Committee on
Health, Education, Labor and Pensions
of the Senate, appropriate scientific and
academic experts, veterinary
professionals, representatives of
consumer advocacy groups, and the
regulated industry in developing
recommendations to Congress for the
reauthorization of ADUFA and for the
goals and plans for meeting the goals
associated with the process for review of
animal drug applications. As directed
by Congress, FDA is holding a public
meeting to gather information on what
features we should propose to include
in the ADUFA program (http://
www.fda.gov/cvm/4218.htm) and hear
stakeholder views on this subject.
We are offering the following two
general questions for consideration, and
we are interested in responses to these
questions and any other pertinent
information stakeholders would like to
share:
1. What is your assessment of the
overall performance of the ADUFA
program thus far?
2. What suggestions or changes would
you make relative to the reauthorization
of ADUFA?
ADUFA, amended the Federal Food,
Drug, and Cosmetic Act (the act) and
authorized FDA to collect fees for
certain animal drug applications,
establishments, products, and sponsors
in support of the review of animal
drugs. These additional resources
support FDA’s responsibilities under
the act to ensure that new animal drug
products are safe and effective for
animals as well as for the public with
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respect to animals intended for food
consumption.
FDA’s animal drug user fee program
was authorized in 2003 and
implemented in 2004. A significant part
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of the preparations for the program
included determining the fee levels for
fiscal year (FY) 2004. ADUFA provides
for the following four fees: (1) A sponsor
fee, (2) an establishment fee, (3) a
product fee, and (4) an application fee.
The act also provides for specific
waivers and exemptions from fees. FDA
prepared guidance for the industry
regarding the fees, billings and
submission of fees, and waivers and
exemptions (http://www.fda.gov/cvm/
adufa.htm).
The total amounts of monies expected
for collection were as follows: $5
million for FY 2004; $8 million in FY
2005; and, $10 million in each FY 2006
through 2008. Each fee type was
expected to be 25 percent of the total
amount collected. Thus, in FY 2006, we
expect to receive $2,500,000 from
sponsor fees, establishment fees,
product fees, and application fees, for a
total of $10,000,000 dollars (figures are
subject to inflation and workload
adjustments). The user fees are used to
achieve shorter, more predictable
review times by increasing the review
staff at FDA and building better
management systems. As a result, we
anticipate substantial savings to the
industry in regulatory review and
developmental expenses.
FDA’s animal drug premarket review
program is making continual and
substantial improvements in the animal
drug review process as a result of user
fees. This helps ensure an adequate
supply of safe and effective therapeutic
and production animal drugs.
We have published a number of
reports that may help inform the public
about the ADUFA program. Key
documents such as ADUFA-related
guidance, legislation, performance
reports, and financial reports, can be
found at http://www.fda.gov/cvm/
adufa.htm.
II. Meeting
FDA will conduct the meeting on
February 24, 2006, at the DoubleTree
Hotel (see Location). In general, the
meeting format will include
presentations by FDA and a series of
panels representing different
stakeholder interest groups (scientific
and academic experts, veterinary
professionals, representatives of
consumer advocacy groups, and the
regulated industry). FDA and panel
presentations are planned from 9 a.m.
until 12 noon. The open public
comment portion of the meeting for
registered speakers is planned to begin
at 1 p.m. An opportunity for public
comments from meeting attendees will
commence following the registered
presentations, if time permits. The
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docket will remain open for written
comments through March 26, 2006, 30
days following the meeting.
If you wish to reserve time to make a
presentation at the meeting, please
contact Aleta Sindelar (see FOR FURTHER
INFORMATION CONTACT) by February 10,
2006. Your request to make a
presentation should include the
following information: Name, company,
company address, company phone
number, and e-mail address. We will try
to accommodate all persons who wish
to make a presentation. The time
allotted for presentations may depend
on the number of persons who wish to
speak.
If you require special
accommodations due to a disability,
please contact the DoubleTree Hotel (see
Location) at least 7 days in advance of
the meeting.
III. Comments
If you would like to submit written
comments to the docket regarding
ADUFA, please send your comments to
the Division of Dockets Management
(See ADDRESSES). Submit a single copy
of electronic comments or two paper
copies of any written comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Received comments may be
reviewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: December 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7876 Filed 12–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders and Genetic Diseases in
Newborns and Children; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Heritable
Disorders and Genetic Diseases in Newborns
and Children (ACHDGDNC).
Dates and Times: February 13, 2006, 9 a.m.
to 5 p.m.; February 14, 2006, 8:30 a.m. to 3
p.m.
Place: Ronald Reagan Building and
International Trade Center, Rotunda Room,
28DEN1